Simultaneous determination of aceclofenac and three of its metabolites in human plasma by high‐performance liquid chromatography

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Abstract
Aceclofenac {[2‐(2′,6′‐dichlorophenyl)amino]phenylacetoxyacetic acid} is a phenylacetic acid derivative with potent analgesic and anti‐inflammatory properties and an improved gastro‐intestinal tolerance. In the present study, a liquid–liquid extraction‐based reversed‐phase HPLC method with UV detection was validated and applied for the analysis of aceclofenac and three of its metabolites (4′‐hydroxy‐aceclofenac, diclofenac, 4′‐hydroxy‐diclofenac) in human plasma. The analytes were separated using an acetonitrile–phosphate buffer gradient at a flow rate of 1 mL/min, and UV detection at 282 nm. The retention times for aceclofenac, diclofenac, 4′‐hydroxy‐aceclofenac, 4′‐hydroxy‐diclofenac and ketoprofen (internal standard) were 69.1, 60.9, 46.9, 28.4 and 21.2 min, respectively. The validated quantitation range of the method was 10–10,000 ng/mL for aceclofenac, 4′‐hydroxy‐aceclofenac and diclofenac, and 25–10,000 ng/mL for 4′‐hydroxy‐diclofenac. The developed procedure was applied to assess the pharmacokinetics of aceclofenac and its metabolites following administration of a single 100 mg oral dose of aceclofenac to three healthy male volunteers. Copyright © 2003 John Wiley & Sons, Ltd.